Safety and Efficacy of Human Mesenchymal Stem Cells for Treatment of Liver Failure

NCT01218464 | Unknown Phase 1 DMC

• 1 other identifier: Beijing302-003
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Liver failure (LF) is a dramatic clinical syndrome with massive necrosis of liver cells. and liver transplantation is the only available therapeutic option for patients suffering with this condition. However, lack of donors, surgical complications, rejection, and high cost are serious problems. Previous study showed that bone marrow derived mesenchymal stem cells (BM-MSCs) replace hepatocytes in injured liver, and effectively rescue experimental liver failure and contribute to liver regeneration. In this study, the patients with LF will undergo administration of human umbilical cord mesenchymal stem cells (UC-MSCs) via peripheral vein transfusion to evaluate the safty and efficacy of UC-MSCs treatment for these patients.

Conditions

Liver Failure; Mesenchymal Stem Cells

Keywords

Liver Failure; Mesenchymal Stem Cells; Model for End-Stage Liver Disease; Ascite; Serum Albumin

Outcome Measures

Primary Outcomes (1)

• The levels of serum Total Protein and Albumin

  2 years after treatment

Secondary Outcomes (8)

• The levels of serum Total Bilirubin and Direct Bilirubin

  2 years after treatment

• The levels of serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Cholinesterase (CHE)

  2 years after treatment

• The level of alpha-fetoprotein (AFP)

  2 years after treatment

• The content of ascites

  2 years after treatment

• Survival rate and time

  2 years after treatment

Study Arms (2)

Conventional plus MSC treatment

EXPERIMENTAL

Participants will receive conventional treatment plus a dose of MSC from day 0 through the week 12 study visit. Participants will then be followed until 2 years study visit

Drug: Conventional plus MSC treatment

Conventional plus pacebo treatment

EXPERIMENTAL

Participants will receive conventional plus placebo treatment from day 0 through the week 12 study visit. Participants will then be followed until 2 years study visit

Drug: Conventional plus pacebo treatment

Interventions

Conventional plus MSC treatment DRUG

Participants received conventional treatment and taken i.v., once per 4 week, at a dose of 0.5\*10E6 MSC/kg body for 12 weeks.

Conventional plus MSC treatment

Conventional plus pacebo treatment DRUG

Participants received conventional treatment and taken i.v., once per 4 week, at 50 ml saline for 12 weeks.

Conventional plus pacebo treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-70 years
• Liver failure
• Negative pregnancy test (female patients in fertile age)
• Written consent

You may not qualify if:

• Hepatocellular carcinoma or other malignancies
• Severe problems in other vital organs(e.g.the heart,renal or lungs)
• Pregnant or lactating women
• Severe bacteria infection
• Anticipated with difficulty of follow-up observation
• Other candidates who are judged to be not applicable to this study by doctors

Sponsors & Collaborators

• Beijing 302 Hospital: lead

Study Sites (1)

Beijing 302 Hospital

Beijing, Beijing Municipality, 100039, China

RECRUITING

Related Publications (5)

• Kuo TK, Hung SP, Chuang CH, Chen CT, Shih YR, Fang SC, Yang VW, Lee OK. Stem cell therapy for liver disease: parameters governing the success of using bone marrow mesenchymal stem cells. Gastroenterology. 2008 Jun;134(7):2111-21, 2121.e1-3. doi: 10.1053/j.gastro.2008.03.015. Epub 2008 Mar 12.

  PMID: 18455168 BACKGROUND

• Campard D, Lysy PA, Najimi M, Sokal EM. Native umbilical cord matrix stem cells express hepatic markers and differentiate into hepatocyte-like cells. Gastroenterology. 2008 Mar;134(3):833-48. doi: 10.1053/j.gastro.2007.12.024. Epub 2007 Dec 23.

  PMID: 18243183 BACKGROUND

• Terai S, Ishikawa T, Omori K, Aoyama K, Marumoto Y, Urata Y, Yokoyama Y, Uchida K, Yamasaki T, Fujii Y, Okita K, Sakaida I. Improved liver function in patients with liver cirrhosis after autologous bone marrow cell infusion therapy. Stem Cells. 2006 Oct;24(10):2292-8. doi: 10.1634/stemcells.2005-0542. Epub 2006 Jun 15.

  PMID: 16778155 BACKGROUND

• Mohamadnejad M, Alimoghaddam K, Mohyeddin-Bonab M, Bagheri M, Bashtar M, Ghanaati H, Baharvand H, Ghavamzadeh A, Malekzadeh R. Phase 1 trial of autologous bone marrow mesenchymal stem cell transplantation in patients with decompensated liver cirrhosis. Arch Iran Med. 2007 Oct;10(4):459-66.

  PMID: 17903050 RESULT

• Kharaziha P, Hellstrom PM, Noorinayer B, Farzaneh F, Aghajani K, Jafari F, Telkabadi M, Atashi A, Honardoost M, Zali MR, Soleimani M. Improvement of liver function in liver cirrhosis patients after autologous mesenchymal stem cell injection: a phase I-II clinical trial. Eur J Gastroenterol Hepatol. 2009 Oct;21(10):1199-205. doi: 10.1097/MEG.0b013e32832a1f6c.

  PMID: 19455046 RESULT

MeSH Terms

Conditions

Liver Failure

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Fu-Sheng Wang, Professor

  Beijing 302 Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fu-Sheng Wang, Professor

CONTACT

86-10-63879735; fswang@public.bta.net.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 8, 2010
• First Posted: October 11, 2010
• Study Start: March 1, 2009
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: May 31, 2013

Record last verified: 2013-05

Locations

CN (1)